81N-0033P
C 26
Volume 90-91

Cover Letter

Comment

Reference List

References

Reference 1 - Food and Drug Administration, Advanced Notice of Proposed Rulemaking, Oral Health Care Drug Products for Over-the-Counter Human Use; Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph, 68 Federal Register 32232-32287, May 29, 2003.

Reference 2 - Cummins, D., “Vehicles: how to deliver the goods”, Periodontology 2000 1997, 15: 84-99.

Reference 3 - Marsh, P. D., “Microbiological aspects of the chemical control of plaque and gingivitis”, JDent Res 1992, 71(7): 1431-1438.

Reference 4 - Brecx, M., “Strategies and agents in supragingival chemical plaque control”, Periodontology 2000 1997, 15: 100-l 08.

Reference 5 - Moran, J. M., ‘Chemical plaque control - prevention for the masses”, Periodonto/ogy2000 1997, 15: 109-117.

Reference 6 - Barnett, M. L., “The role of therapeutic antimicrobial mouthrinses in clinical practice: Control of supragingival plaque and gingivitis”, J Am Dent Assoc 2003,134:699-704.

Reference 7 - Arweiler, N. B., Sculean, A., Auschill, T. M., “Delmopinol - an alternative to chlorhexidine?“, Schweiz Monatsschr Zahnmed 2003, 113(2): 136-142.

Reference 8 - Wu, C. D., Savitt, E. D., “Evaluation of the safety and efficacy of over-thecounter oral hygiene products for the reduction and control of plaque and gingivitis”, Periodontology 2000 2002, 28: 91-105.

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Reference 10 - Winston, J. L., Bartizek, R. D., McClanahan, S. F., Mau, M. S., Beiswanger, B. B., “A clinical methods study of the effects of triclosan dentifrices on gingivitis over six months”, J Clin Dent 2002, 13(6): 240-
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Reference 12 - Svatun, B., Saxton, C. A., Huntington, E., Cummins, D., “The effects of three silica dentifrices containing triclosan on supragingival plaque and calculus formation and on gingivitis”, International Dental Journal 1993, 43(4): 441-452.

Reference 13 - Grossman, E., Hou, L., Bollmer, B. W., Court, L. K., McClary, J. M., Bennett, S., Winston, J. L., McClanahan, S. F., “Triclosan/pyrophosphate dentifrice: Dental plaque and gingivitis effects in a 6-month randomized controlled clinical study”, J Clin Dent 2002, 13(4): 149-157.

Reference 14 - Lang, N. P., Sander, L., Barlow, A., Brennan, K., White, D. J., Bacca, L., Bartizek, R. D., McClanahan, S. F., “Experimental Gingivitis Studies: Effects of triclosan and triclosan-containing dentifrices on dental plaque and gingivitis in three-week randomized controlled clinical trials”, J Clin Dent 2002, 13(4): 158-166.

Reference 15 - Peter, S., Nayak, D. G., Phillip, P., Bijlani, N. S., “Antiplaque and antigingivitis efficacy of toothpastes containing triclosan and fluoride”, International Dental Journal 2004, 54(5): 299-303.

Reference 16 - Cummins, D., Creeth, J. E., “Delivery of antiplaque agents from dentifrices, gels, and mouthwashes”, J Dent Res 1992, 71(7): 1439-1449.

Reference 17 - van der Ouderaa, F. J., Cummins, D., “Delivery systems for agents in supra- and sub-gingival plaque control”, J Dent Res 1989, 68(Spec Iss): 1617-1624.

Reference 18 - Cummins, D., “Mechanisms of action of clinically proven anti-plaque agents”, In Clinical and Biological Aspects of Dentifrices (eds. Embery, G., Rolla, G.), Oxford University Press, 1992, pp. 205-228.

Reference 19 - Brading, M. G., Marsh, P. D., “The oral environment: the challenge for antimicrobials in oral care products”, lnternafional Dental Journal 2003, 53(6): 353-362.

Reference 20 - Mustafa, M., Wondimu, B., Ibrahim, M., Modeer, T., “Effect of triclosan on interleukin-1B production in human gingival fibroblasts challenged with tumor necrosis factor a”, Eur J Oral Sci 1998, 106: 637-643.

Reference 21 - Modeer, T., Bengtsson, A., Rolla, F., “Triclosan reduces prostaglandin biosynthesis in human gingival fibroblasts challenged with interleukin-1 in vitro”, J Clin Periodontol 1996, 23: 927-933.

Reference 22 - Gaffar, A., Nabi, N., Kashuba, B., Williams, M., Herles, S., Olsen, S., Afflitto, J., “Antiplaque effects of dentifrices containing triclosan/copolymer/NaF system versus triclosan dentifrices without the
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Reference 23 - Ritchie, J. A., Jones, C. L., “The inhibition of facultative and obligate anaerobic bacteria by triclosan” In Anaerobes Today (eds. Hardie, J. M., Borriello, S. P.), Wiley, 1988, pp. 240-241.

Reference 24 - Meincke, B. E., Kraz, R. G., Lynch, D. L., “Effect of lrgasan on bacterial growth and its adsorption into the cell wall” Microbios 1980, 28(113-l 14): 133-147.

Reference 25 - Suller, M. T. E., Russell, A. D., “Triclosan and antibiotic resistance in Staphylococcus aureus”, Journal of Antimicrobial Chemotherapy 2000, 46: 11-18.

Reference 26 - Russell, A. D., “Similarities and differences in responses of microorganisms to biocides”, Journal of Antimicrobial Chemotherapy 2003, 52: 750-763.

Reference 27 - Colgate-Palmolive Company Patents.

Patent 1 - US4894220: Antibacterial Antiplaque Oral Composition, Colgate-Palmolive Company, January 16, 1990.

Patent 2 - US5037635: Antibacterial Antiplaque Oral Composition, Colgate-Palmolive Company, August 6, 1991.

Patent 3 - US5037637: Antibacterial Antiplaque, Anticalculus Oral Composition, Colgate-Palmolive Company, August 6, 1991.

Patent 4 - US50431 54: Antibacterial Antiplaque, Anticalculus Oral Composition, Colgate-Palmolive Company, August 27, 1991.

Patent 5 - US5080887: Antibacterial Antiplaque, Anticalculus Oral Composition, Colgate-Palmolive Company, January 14, 1992.

Patent 6 - US51 56835: Antibacterial Antiplaque Oral Composition, Colgate-Palmolive Company, October 20, 1992.

Patent 7 - US5180578: Antibacterial Antiplaque Anticalculus Oral Composition, Colgate-Palmolive Company, January 19, 1993.

Patent 8 - US5292526: Antibacterial Antiplaque Anticalculus Oral Composition, Colgate-Palmolive Company, March 8, 1994.

Patent 9 - US5344641 : Antibacterial Antiplaque Oral Composition, Colgate-Palmolive Company, September 6, 1994.

Patent 10 - US553871 5: Antibacterial Antiplaque Oral Composition, Colgate-Palmolive Company, July 23, 1996.

Patent 11 - US5686064: Antibacterial Antiplaque, Anticalculus Oral Composition, Colgate-Palmolive Company, November 11, 1997.

Patent 12 - US5776435: Antiplaque Antibacterial Oral Composition, Colgate-Palmolive Company, July 7, 1998.

Reference 28 - Svatun, B., Saxton, C. A., Huntington, E., Cummins, D., “The effects of a silica dentifrice containing triclosan and zinc citrate on supragingival plaque and calculus formation and the control of gingivitis”, International Dental Journal 1993, 43: 431-439.

Reference 29 - Gjermo, P., Saxton, C. A., “Antibacterial dentifrices. Clinical data and relevance with emphasis on zinc/triclosan”, J Clin Periodontol 1991, 18: 468-473.

Reference 30 - Svatun, B., Saxton, C. A., Rolla, G., van der Ouderaa, F., “One-year study of the efficacy of a dentifrice containing zinc citrate and triclosan to maintain gingival health”, Stand J Dent Res 1989, 97: 242-246.

Reference 31 - Svatun, B., Saxton, C. A., Rolla, G., ‘Six-month study of the effect of a dentifrice containing zinc citrate and triclosan on plaque, gingival health, and calculus”, Stand J Dent Res 1990, 98: 301-304.

Reference 32 - Svatun, B., Saxton, C. A., Rolla, G., van der Ouderaa, F., “A l-year study on the maintenance of gingival health by a dentifrice containing a zinc salt and non-anionic antimicrobial agent”, J Clin Periodontol 1989, 16: 75-80.

Reference 33 - Svatun, B., Saxton, C. A., van der Ouderaa, F., Rolla, G., “The influence of a dentifrice containing a zinc salt and a nonionic antimicrobial agent on the maintenance of gingival health”, J Clin Periodontol 1987, 14: 457-461.

Reference 34 - Stephen, K. W., Saxton, C. A., Jones, C. L., Ritchie, J. A., Morrison, T., “Control of gingivitis and calculus by a dentifrice containing a zinc salt and triclosan”, J Periodontol 1990, 61: 674-679.

Reference 35 - Marsh, P. D., “Dentifrices containing new agents for the control of plaque and gingivitis: microbiological aspects”, J Clin Periodontol 1991, 18: 462- 467.

Reference 36 - Cummins, D., “Zinc citrate/Triclosan: a new anti-plaque system for the control of plaque and the prevention of gingivitis: short-term clinical and mode of action studies”, J Clin Periodontol 1991, 18: 455-461.